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Manager, Regulatory Affairs

Company

Takeda

Location

Gurgaon, Haryana

Type

Full time

Description

OBJECTIVES/PURPOSE:

Manager Regulatory Affairs ensures obtaining regulatory approval for products and life cycle management of products and regulatory submission with Indian Health Authority (CDSCO) and NMRA Sri Lanka. This role helps Takeda navigate complex regulatory landscapes, ensuring regulatory compliances with respect to the Health Authority and facilitating the successful maintenance of products registration and licenses.

KEY JOBS ACCOUNTABILITIES:

  • Managing regulatory approval for products and life cycle management of products of regulatory compliance with Indian Health Authority (CDSCO).
  • Manage the regulatory submission of product for regulatory approvals like Marketing Authorization, Registration certificate, Import License, variation submission/Post approval changes and labels updates any submission related to life cycle management of product with Indian Health Authority (CDSCO) and NMRA, Sri-Lanka...

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